Gastric UltrasoundGASTRIC-USGNCT07352202
Ultrasound Assessment of Gastric Emptying in Mechanically Ventilated ICU Patients
An observational study of Gastric Ultrasound, run by Sehit Prof. Dr. Ilhan Varank Sancaktepe Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
This prospective observational study aims to evaluate dynamic changes in gastric volume and gastric emptying time using bedside gastric ultrasound in mechanically ventilated intensive care unit patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Gastric Ultrasound
- What is being tested?
- Enteral Nutrition (Routine Clinical Care)
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 22 Oct 2025to 13 Sep 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The study population consists of adult patients aged 18 years and older who are mechanically ventilated and admitted to the intensive care unit. Eligible patients are those receiving enteral nutrition via a nasogastric tube as part of routine clinical care and who are hemodynamically stable. Patients will be observed prospectively without any protocol-driven intervention.
Who may be able to join
- Age 18 years or older
- Mechanically ventilated patients admitted to the intensive care unit
- Presence of a nasogastric tube
- Hemodynamically stable patients receiving enteral nutrition as part of routine clinical care
Who cannot join
- Recent abdominal surgery within the first 24 hours
- Major abdominal trauma or burns
- Significant ascites
- Inadequate ultrasound window (e.g., severe meteorism)
- Hemodynamic instability
- Contraindication to enteral nutrition
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Sancaktepe Şehit Prof. Dr. İlhan Varank Training and Research Hospital
Istanbul, Istanbul, 34000
About this study
Official title: Evaluation of Gastric Emptying and Residual Volume Using Ultrasound in Mechanically Ventilated Intensive Care Patients Receiving Different Enteral Nutrition Solutions
This prospective observational study aims to evaluate dynamic changes in gastric volume and gastric emptying time using bedside gastric ultrasound in mechanically ventilated intensive care unit patients. The study compares gastric emptying patterns among patients receiving different types of enteral nutrition solutions as part of routine clinical care.
Read the detailed description
This prospective observational study is designed to evaluate gastric emptying and changes in gastric volume using bedside gastric ultrasound in mechanically ventilated intensive care unit patients. Ultrasound examinations will be performed at predefined time points to assess gastric residual volume and gastric emptying patterns.
Patients receiving different types of enteral nutrition solutions as part of routine clinical care will be evaluated and compared. Gastric measurements will be obtained using standardized ultrasound techniques by trained clinicians.
The study aims to identify differences in gastric emptying dynamics associated with various enteral nutrition formulations and to assess the feasibility of bedside ultrasound as a non-invasive tool for monitoring gastric function in critically ill patients.
- Conditions
- Gastric Ultrasound
- Being tested
- Enteral Nutrition (Routine Clinical Care)
- Keywords
- gastric ultrasound, ıntensive care unit, gastric residual volume
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Enteral Nutrition (Routine Clinical Care)Other
Enteral nutrition administered according to routine clinical practice without protocol-driven assignment or modification.
| Study group | Role | What they receive |
|---|---|---|
| Standard Enteral Nutrition | Mechanically ventilated intensive care unit patients receiving standard enteral nutrition as part of routine clinical care. Receives: Other: Enteral Nutrition (Routine Clinical Care) | |
| Specialized Enteral Nutrition | Mechanically ventilated intensive care unit patients receiving specialized enteral nutrition formulations according to routine clinical practice. Receives: Other: Enteral Nutrition (Routine Clinical Care) | |
| Water Administration | Mechanically ventilated intensive care unit patients receiving water administration via nasogastric tube as part of routine care. Receives: Other: Enteral Nutrition (Routine Clinical Care) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Gastric Volume Estimated by Ultrasound
Dynamic changes in gastric volume estimated using ultrasound-derived antral cross-sectional area measurements at predefined time points before and after enteral feeding.
Measured: Baseline and up to 60 minutes after enteral feeding
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jan 2026
- Study start22 Oct 2025
- Primary completion13 Sep 2026
- Study completion13 Sep 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastric UltrasoundStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sehit Prof. Dr. Ilhan Varank Sancaktepe Training and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Berfin Gizem G Özelsel, MD, Principal investigator, Sehit Prof. Dr. Ilhan Varank Sancaktepe Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07352202
- Sponsor's protocol ID
- 2025-395
- Acronym
- GASTRIC-USG
- Status last verified
- Sep 2026
- First submitted
- 11 Jan 2026
- Last updated
- 15 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared due to institutional data protection policies and the inclusion of critically ill patients. Data will be analyzed and reported in an aggregated and anonymized manner.
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Gastric Emptying and Residual Volume Using Ultrasound in Mechanically Ventilated Intensive Care Patients Receiving Different Enteral Nutrition Solutions
- ClinicalTrials.gov ID
- NCT07352202
- Acronym / sponsor ID
- GASTRIC-USG / 2025-395
- Conditions
- Gastric Ultrasound
- Keywords
- gastric ultrasound, ıntensive care unit, gastric residual volume
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Sehit Prof. Dr. Ilhan Varank Sancaktepe Training and Research HospitalUniversity, hospital or other
- Study start
- 22 Oct 2025 (actual)
- Primary completion
- 13 Sep 2026 (actual)
- Study completion
- 13 Sep 2026 (actual)
- First posted
- 20 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This prospective observational study aims to evaluate dynamic changes in gastric volume and gastric emptying time using bedside gastric ultrasound in mechanically ventilated intensive care unit patients. The study compares gastric emptying patterns among patients receiving different types of enteral nutrition solutions as part of routine clinical care.
Detailed description
This prospective observational study is designed to evaluate gastric emptying and changes in gastric volume using bedside gastric ultrasound in mechanically ventilated intensive care unit patients. Ultrasound examinations will be performed at predefined time points to assess gastric residual volume and gastric emptying patterns.
Patients receiving different types of enteral nutrition solutions as part of routine clinical care will be evaluated and compared. Gastric measurements will be obtained using standardized ultrasound techniques by trained clinicians.
The study aims to identify differences in gastric emptying dynamics associated with various enteral nutrition formulations and to assess the feasibility of bedside ultrasound as a non-invasive tool for monitoring gastric function in critically ill patients.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Standard Enteral Nutrition | – | Other: Enteral Nutrition (Routine Clinical Care)Mechanically ventilated intensive care unit patients receiving standard enteral nutrition as part of routine clinical care. |
| Specialized Enteral Nutrition | – | Other: Enteral Nutrition (Routine Clinical Care)Mechanically ventilated intensive care unit patients receiving specialized enteral nutrition formulations according to routine clinical practice. |
| Water Administration | – | Other: Enteral Nutrition (Routine Clinical Care)Mechanically ventilated intensive care unit patients receiving water administration via nasogastric tube as part of routine care. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population consists of adult patients aged 18 years and older who are mechanically ventilated and admitted to the intensive care unit. Eligible patients are those receiving enteral nutrition via a nasogastric tube as part of routine clinical care and who are hemodynamically stable. Patients will be observed prospectively without any protocol-driven intervention.
Key inclusion criteria (4 listed)
- Age 18 years or older
- Mechanically ventilated patients admitted to the intensive care unit
- Presence of a nasogastric tube
- Hemodynamically stable patients receiving enteral nutrition as part of routine clinical care
Key exclusion criteria (6 listed)
- Recent abdominal surgery within the first 24 hours
- Major abdominal trauma or burns
- Significant ascites
- Inadequate ultrasound window (e.g., severe meteorism)
- Hemodynamic instability
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Enteral Nutrition (Routine Clinical Care)Enteral nutrition administered according to routine clinical practice without protocol-driven assignment or modification. | Other | Specialized Enteral Nutrition, Standard Enteral Nutrition, Water Administration |
Primary outcome
Change in Gastric Volume Estimated by Ultrasound
Time frame: Baseline and up to 60 minutes after enteral feeding
Dynamic changes in gastric volume estimated using ultrasound-derived antral cross-sectional area measurements at predefined time points before and after enteral feeding.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Sep 2026.
- Individual participant dataSharing planned: No. Individual participant data will not be shared due to institutional data protection policies and the inclusion of critically ill patients. Data will be analyzed and reported in an aggregated and anonymized manner.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Berfin Gizem G Özelsel, MD principal investigator
Sehit Prof. Dr. Ilhan Varank Sancaktepe Training and Research Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Gastric Ultrasound, run by Sehit Prof. Dr. Ilhan Varank Sancaktepe Training and Research Hospital at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Gastric Volume Estimated by Ultrasound (time frame: Baseline and up to 60 minutes after enteral feeding). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Sep 2026.